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Maintenance Treatment of Apatinib in Nasopharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03130270
Recruitment Status : Active, not recruiting
First Posted : April 26, 2017
Last Update Posted : May 16, 2018
Sponsor:
Collaborators:
Wuzhou Red Cross Hospital
Guangxi Naxishan Hospital
National Hospital of Guangxi Zhuang Autonomous Region
Information provided by (Responsible Party):
Wei Jiang, Guilin Medical University, China

Brief Summary:
The study is to evaluate the efficacy and safety of Apatinib for later treatment of patients(after second-line treatment for locally recurrent or metastatic nasopharyngeal carcinoma), including overall survival (OS), distant metastasis-free survival (DMFS) and locoregional relapse-free survival (LRRFS); the relationship between EBV DNA copy number and survival after radiotherapy or radiochemotherapy; Quality of life score (QoL); evaluation of drug safety.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Apatinib mesylate tablet Phase 2

Detailed Description:
In locally advanced nasopharyngeal carcinoma(NPC), although fist-line therapy with radiotherapy and chemotherapy (Cisplatin/Docetaxel/5-Fu) and second-line therapy with chemotherapy has been given, patients still locally recurrence and distant metastasis. There is no standard treatment recommendation for locally recurrent or metastatic NPC who failed to second-line therapy. Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III studies of liver cancer, non small cell lung cancer and other tumors also showed apatinib has less toxicities and better tolerance. However, the clinical application of apatinib in nasopharyngeal carcinoma is still lack of evidence-based medicine. And this trial is designed to investigate the efficacy and safety of apatinib in locally recurrent or metastatic NPC.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Maintenance Apatinib After Second-Line Treatment for Locally Recurrent or Metastatic Nasopharyngeal Carcinoma
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : April 8, 2019
Estimated Study Completion Date : December 8, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Apatinib group
Apatinib mesylate tablet:the starting dose was 500 mg, orally, qd; tolerance assessment for a cycle, patients with poorly tolerance were treated with low dose (500 mg, qd), and patients with well tolerance were treated with high dose (750 mg, qd).
Drug: Apatinib mesylate tablet

Patients with locally recurrent or metastatic nasopharyngeal carcinoma (NPC) after second-line treatment are assigned to receive apatinib mesylate tablet. A treatment cycle was defined as 28 days (4 weeks). The starting dose was 500 mg, orally, qd; tolerance assessment for a cycle, patients with poorly tolerance were treated with low dose (500 mg, qd), and patients with well tolerance were treated with high dose (750 mg, qd). All patients continuous treatment until progression disease or non-tolerated toxicity.

Note: good tolerance was defined that no grade 3/4 hematology or/and non hematologic side effects occurred within 4 weeks after initiation treatment; poor tolerance was defined that grade 3/4 hematology or/and non hematologic side effects appeared within 4 weeks after initiation treatment.

Other Name: No.




Primary Outcome Measures :
  1. Objective Response Rate (ORR) after Second-Line Treatment for Locally Recurrent or Metastatic Nasopharyngeal Carcinoma [ Time Frame: up to 24 months ]
    To evaluate ORR every 6-8 weeks after initiation of apatinib.


Secondary Outcome Measures :
  1. Disease-free survival (DFS) [ Time Frame: up to 24 months ]
    The time from the first day of therapy to locoregional relapse, distant relapse again or tumor-related death.

  2. Overall survival (OS) [ Time Frame: up to 24 months ]
    The time from the first day of therapy to death or last follow-up.

  3. Toxicity evaluation [ Time Frame: up to 24 months ]
    Related toxicities were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients aged ranging from 18 to 70 years old.
  2. Patients with newly histologically proven nasopharyngeal carcinoma (NPC).
  3. Local recurrent NPC patients after comprehensive treatment, including clinical examination found a clear local area residue: electronic nasopharyngoscope found clear residual or enlarged cervical lymph nodes.
  4. Distant metastatic NPC patients after comprehensive treatment, including liver B ultrasound, chest X-ray, bone scan or other clinicians consider appropriate tests such as CT, MRI or PET/CT found distant metastases.
  5. Comprehensive treatment of local recurrence or distant metastasis after line or second-line therapy found progressive disease.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
  7. Patient who has the expected survival time more than 3 months.
  8. Adequate hematological function: hemoglobin >80 g/L (no transfusion within 14 days), neutrophil count > 1.5×109/L, platelet count 80×109/L.
  9. Adequate liver function (serum total bilirubin ≤ 1.5 mg/dL, serum transminase ≤ 2.5 times higher than upper limit).
  10. Adequate renal function (creatinine clearance ≥ 50 mL/min).
  11. Participants volunteered to participate in this study, signed informed consent, good compliance and cooperated with us to complete the follow-up.

Exclusion Criteria:

  1. Before treatment, MRI showed that the tumor might be an important risk factor (for example, wrapping around the internal carotid artery / vein); or researchers judged that the tumor is a high risk of serious blood vessel bleeding during the treatment.
  2. Patient who has serious hemorrhages, any serious bleeding events classification at 3 degree or more (according to CTCAE4.0) within the last 4 weeks.
  3. Patient who has high blood pressure can not be controlled by a single antihypertensive drug treatment (Systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg); any unstable angina pectoris; with a history of angina pectoris were newly diagnosed with angina pectoris within 3 months before screening; any myocardial infarction events occurred within 6 months before screening; arrhythmia (including QTcF: male ≥ 450ms, female ≥ 470 ms) need long time use of antiarrhythmic drugs and heart function insufficiency ≥II according to New York Heart Association class.
  4. Patient who has positive urine protein.
  5. Patient who has abnormal coagulation and bleeding tendency (signed informed consent before 14 days, and must be satisfied: INR is in the normal range without the use of anticoagulants); Application of anticoagulants or vitamin K antagonists such as Hua Falin, heparin or its analogues, with international normalized ratio (INR) is less than 1.5, allows the use of small dose Hua Falin (1 mg orally, once daily) or small dose aspirin (total dose ≤ 100 mg daily).
  6. Medical history of arteriovenous thrombosis event within the past year, such as cerebral vascular accident (including transient ischemic attack) and deep venous thrombosis (venous catheter thrombosis caused by chemotherapy and investigator judged that the patient had recovered, these patients should be except) and pulmonary embolism.
  7. A healed wound for long time or incomplete fracture.
  8. Any factors that affect the oral drug, such as the inability to swallow, diarrhea and intestinal obstruction.
  9. For females: patients should be surgical sterilization or postmenopausal patients, or willing to receive a medical approved contraception during treatment and 6 months after the end of the treatment; serum or urine pregnancy test must be negative, and must be non lactating period within 7 days before study; for males: patients should be treated with surgical sterilization or willing to receive a medical approved contraception during treatment and 6 months after the end of the treatment.
  10. History of psychotropic substance abuse and can not be removed or psychiatric disorders.
  11. Medical history of immunodeficiency, or other acquired, congenital immunodeficiency disease, or history of organ transplantation.
  12. Any serious harm to the subject's safety or evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130270


Locations
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China, Guangxi
Guilin Medical University
Guilin, Guangxi, China, 541001
Nanxishan hospital
Guilin, Guangxi, China
National Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China
Sponsors and Collaborators
Guilin Medical University, China
Wuzhou Red Cross Hospital
Guangxi Naxishan Hospital
National Hospital of Guangxi Zhuang Autonomous Region
Investigators
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Principal Investigator: Wei Jiang Guilin Medical University

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Responsible Party: Wei Jiang, Guilin Medical University, Guilin Medical University, China
ClinicalTrials.gov Identifier: NCT03130270     History of Changes
Other Study ID Numbers: GLMU-02
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wei Jiang, Guilin Medical University, China:
nasopharyngeal carcinoma
disease-free survival
adverse reaction
Additional relevant MeSH terms:
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Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Carcinoma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action